The Study Evaluating the Improvement of Nutritional Status and Frailty With Silkworm Pupa Powder Among Patients With Motor Neuron Disease

Official title

A Prospective, Double-blind, Randomized Controlled Study Evaluating the Improvement of Nutritional Status and Frailty With Silkworm Pupa Powder Compared With Placebo Among Motor Neuron Disease

Overview

Motor Neuron Disease (MND) is the result of dysfunction of the upper motor neurons in the precentral gyrus of the frontal lobe or the lower motor neurons in the ventral horn of the spinal cord. Amyotrophic lateral sclerosis (ALS) is the most common, disabling, and fatal motor neuron disease in adults. Sarcopenia is a syndrome characterized by progressive loss of skeletal muscle mass, accompanied by a reduction in muscle strength and (or) function, and it is an important feature of MND. Aging is an objective and inevitable process that involves the gradual degeneration and loss of physiological functions in various tissues, organs, and cells. With the continuous accumulation of various injuries, the body eventually exhibits signs of frailty such as fatigue, reduced muscle strength, and weight loss. Data from adult ALS patients indicate that 58% of patients are at risk of frailty. Silkworm pupa contains high-quality animal protein and has a wide range of activities in antioxidant, antitumor, antibacterial, and immune enhancement, making it highly nutritious and medicinally valuable. Silkworm pupa extracts can enhance grip strength in older adults with relatively low skeletal muscle mass. As a natural food ingredient with high safety, the value of silkworm pupa in ALS patients lacks corresponding research, which limits its further application in clinical practice. This study aims to select ALS patients as the research subjects and use a randomized, controlled, double-blind prospective study design to evaluate the effectiveness of silkworm pupa tablets in improving sarcopenia, frailty, and quality of life in ALS patients. The study strives to improve the frailty condition of ALS patients and enhance their quality of life by supplementing nutrition, thereby providing new strategies for comprehensive intervention and management of ALS patients.

Interventions

• Other Chinese medicine - Silkworm pupa powder
  Silkworm pupa contains high-quality animal protein and has a wide range of activities in antioxidant, antitumor, antibacterial, and immune enhancement, making it highly nutritious and medicinally valuable.
• Other Ultra-low dose silkworm pupa powder
  0.5% of the effective components in the experimental group

Primary outcome measures

• Assessing patient nutritional improvement using Third Lumbar Skeletal Muscle Index (L3-SMI). [Time frame: The 0th、 4th 、8th and 12th week after taking Silkworm Silkworm pupa powder.]
• The improvement of frailty in patients treated by the Frailty Phenotype (FP) Scale assessment. [Time frame: The 0th、 4th 、8th and 12th week after taking Silkworm Silkworm pupa powder.]

Secondary outcome measures (2)

• Using the Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R) to assess patient functional status, thereby evaluating the improvement of neurological dysfunction. [Time frame: The 0th、 4th 、8th and 12th week after taking Silkworm Silkworm pupa powder.]
• Assess the respiratory function of patients with Amyotrophic Lateral Sclerosis undergoing treatment using the Oxygenation Index. [Time frame: The 0th、 4th 、8th and 12th week after taking Silkworm Silkworm pupa powder.]

Eligibility criteria

Inclusion criteria

• Voluntarily participate in the clinical study, fully understand and be informed about the study, and sign the Informed Consent Form (ICF); willing to follow and capable of completing all trial procedures.
• Gender is not limited, age at the time of signing ICF: ≥18 years old, ≤80 years old; if the ALS patient is at least 18 years old, then the weight must be over 40 kilograms.
• Diagnosis conforms to the confirmed and probable ALS in the ALS2020 diagnostic criteria (Gold Coast Criteria).
• Clinical, neurophysiological, or pathological examination confirms evidence of lower motor neuron involvement.
• Frailty Phenotype scale (FP) ≥1.
• Exclude other diseases.
• Agree to provide peripheral blood, fecal, and urine samples for biomarker analysis during the study period.

Exclusion criteria

• Patients with other neurological diseases similar to ALS symptoms or affecting drug efficacy evaluation, such as cervical spondylosis, lumbar disease, dementia, etc.
• Patients with other autoimmune diseases, such as Multiple Sclerosis (MS), Polymyositis, Myasthenia Gravis, Guillain-Barré Syndrome, Ankylosing Spondylitis, Rheumatoid Arthritis, Systemic Lupus Erythematosus, Vitiligo, etc.
• Severe renal insufficiency: Creatinine clearance < 30 mL/min (Cockcroft-Gault formula), or other known severe renal insufficiency diseases.
• Severe liver damage: ALT, AST > 3 times the upper limit of normal, or other known liver diseases such as acute and chronic active hepatitis, cirrhosis, etc.
• Patients with severe pulmonary function insufficiency such as Chronic Obstructive Pulmonary Disease (COPD), pulmonary fibrosis, etc.
• During the screening period, patients with acute myocardial infarction or interventional treatment within the last 6 months, heart failure patients (classified as NYHA class III-IV patients).
• Patients with other severe primary diseases of the nervous system, heart, lungs, hematopoietic system, or endocrine system, and mental illness patients.
• Those suspected or confirmed to have a history of alcohol or drug abuse.
• Expected survival ≤ 3 months.
• Pregnant or breastfeeding women, subjects of reproductive age (including male subjects who have had heterosexual intercourse and their female partners with childbearing potential) who plan to become pregnant or are unwilling to take effective contraceptive measures from the start of screening to 3 months after discontinuing medication.
• Those who are allergic to known ingredients of the trial products; or have a history of drug allergies or severe allergic diseases (anaphylactic shock, etc.).
• During the study, individuals assessed by researchers as potential drug abusers who may affect the efficacy of therapeutic drugs.
• Presence of other severe physical or mental diseases or abnormal laboratory tests that may increase the risk of participating in the study and patients deemed unsuitable for participation by the researcher.
• Patients with malignant tumors.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Treatment

Study locations

China · 1 center

• Hangzhou First People's Hospital — Hangzhou

Identifiers

NCT: NCT06765499 · ZN-2024308-02

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗